Manipulation of an organ

ABSTRACT

Devices for and methods of moving, manipulating, or holding an organ of the body, particularly a heart, are disclosed. A manipulating device includes a seal member, which includes two or more protrusions, that adheres to the surface of the organ when vacuum pressure is applied to a chamber defined by an inner surface of the seal member. The seal member may be made of a substantially compliant and flexible material. The protrusions may enable the seal member to more easily conform to the irregular shape of the organ, may accommodate patient-to-patient variations in the size and shape of organs, may increase the strength of the attachment between the seal member and the organ, may reduce the likelihood of damage to the surface of the organ and may expose areas of the organ for surgical procedures.

[0001] This application claims priority from U.S. ProvisionalApplication Serial No. 60/336,345, filed Oct. 18, 2001, the entirecontent of which is incorporated herein by reference.

TECHNICAL FIELD

[0002] The invention relates to devices capable of providing adherenceto organs of the body for purposes of medical diagnosis and treatment.More particularly, the invention relates to devices capable of adheringto, and moving, manipulating, or holding an organ of the body,particularly a heart, for purposes of medical diagnosis and treatment.

BACKGROUND

[0003] In many areas of surgical practice, it may be desirable tomanipulate an internal organ without causing damage to that organ. Insome circumstances, a surgeon may wish to turn, lift, or otherwisere-orient the organ so that surgery can be performed upon it. In othercircumstances, a surgeon may wish to move the organ out of the surgicalfield of view. In still other circumstances, a surgeon may need to bothre-orient the organ and also hold the organ in the new position tofacilitate physical access to a specific part of the organ not readilyaccessible in the previous position.

[0004] Manipulating or holding the organ with the hands may not befeasible, safe, or optimal to the surgical activities to be performed.Many organs are slippery and are difficult manipulate or hold with thehands. Moreover, the surgeon's hands may not be able to manipulate orhold the organ, and perform the procedure at the same time.

[0005] The hands of an assistant may be bulky, becoming an obstacle tothe surgeon. The hands of an assistant may be a particular problem insituations where surgery is to be performed on the organ. Also, manualsupport of an organ over an extended period of time can be difficult dueto fatigue. Manipulating or holding an organ with an instrument, on theother hand, may damage the organ, especially if the organ is undulysqueezed, pinched, or stretched. Further, holding an organ improperlymay also adversely affect the functioning of the organ.

[0006] The heart is an organ that can be more effectively treated insome surgical procedures if it can be manipulated. Typically, apatient's chest is opened via a sternotomy, the ribs pushed aside with aretractor, and the pericardial sac opened to expose the heart. In thispresentation, the surgeon has primary access only to the anteriorsurface of the heart. In the case of treating cardiovascular disease byrepairing partially or completely occluded coronary arteries, it isnecessary to repair arteries located not only on the anterior surface ofthe heart, but also on the posterior and/or lateral surfaces of theheart. This procedure is referred to as cardiac artery bypass grafting(CABG).

[0007] CABG may be performed by surgeons upon hearts using the procedureof cardiopulmonary bypass (CPB), in which the beating of the heart isstopped by physiologic means and the patient's blood is circulated awayfrom the heart and lungs and into a heart-lung machine for oxygenation.Although manipulating and holding the heart are still problematic usingCPB, the procedure may permit the surgeon to manually manipulate thestopped heart using hands, portions of the pericardial sac, and sutures,permitting access to posterior, lateral and anterior heart surfaces.CPB, however, entails trauma to the patient, with attendant side effectsand risks.

[0008] Recently, surgeons have developed methods to perform CABG on thebeating heart, without CPB. CABG on a beating heart, referred to as “offpump” or “beating heart” surgery, offers reduced morbidity to thepatient, but presents increased technical challenges to the surgeon, whomust now lift and manipulate a beating heart to access the posterior andlateral surfaces without interfering with the effective normal output orhemodynamics of the heart. For example, merely lifting the beating heartwith the hand can potentially cause partial obstruction of the bloodflow out of the heart with a dangerous transient drop in blood pressure.Further, held insecurely, the heart may drop back into the chest, whichmay cause trauma to the heart, and may interfere with the progress ofthe operation.

[0009] While cardiothoracic surgeons have developed a variety of methodsto manipulate the heart, the methods may be cumbersome, or may entailrisk to the patient, or may not permit a sufficient operative field forthe surgeon.

SUMMARY

[0010] The invention presents an organ manipulation device for adheringto, and moving, manipulating, or holding an organ of the body. It shouldbe noted that any references to “adhesion” or related terms do not usethe term as it is frequently used in medicine, namely to describe anabnormal union of an organ or part with some other part by formation offibrous tissue. Rather “adhesion” and related words refer to adherence,the process or one thing holding fast to another, without them becomingpathologically joined.

[0011] The organ manipulation device of the present invention providesfor secure attachment to the organ, minimally interferes with thesurgical field, and does not require the use of the surgeon's orassistant's hand. In addition, the device does not cause irreparabledamage to the surface of the organ such as abrasion, laceration, orperforation. Some embodiments of the invention provide a device for anda method of repositioning the beating heart that enable the surgeon tolift and hold the heart without interfering with its hemodynamicfunction.

[0012] One embodiment of the organ manipulation device of the presentinvention comprises a seal member that contacts the surface of an organ.The seal member includes an inner surface that defines a chamber whenthe seal member is in contact with the surface of the organ. The sealmember also includes a central body and at least two protrusions thatextend outward from the central body. The protrusions may besubstantially flexible and compliant.

[0013] The seal member may also include a distal edge that extendsaround the perimeter of the seal member and contacts the surface of theorgan. The device may also include a coating located on the distal edge.The coating may be tacky.

[0014] In another embodiment, the organ manipulation device of thepresent invention comprises a seal member that contacts the surface ofan organ. The seal member includes a central member, a skirt-likemember, and at least two protrusions that extend outward from a centralportion of the seal member. The skirt-like member may be substantiallycompliant and tacky. The central member may be less deformable than theskirt-like member, thereby imparting structural integrity to the sealmember.

[0015] The invention also presents a method of adhering the organmanipulation device to an organ and moving, manipulating or holding theorgan. One embodiment of the method comprises bringing a seal memberinto contact with a surface of an organ to define a chamber. The sealmember has at least two protrusions. The method further comprisesbringing the two protrusions into contact with the surface of the organand applying vacuum pressure to the chamber to adhere the seal member tothe surface of the organ.

[0016] The organ may be manipulated by manipulating the seal member. Theorgan may be manipulated by manipulating a handle attached to the sealmember. Additionally, the organ may be held in a position by attachingthe seal member to a support. If the organ is a heart, pacing pulses maybe delivered to the heart.

[0017] Embodiments of the present invention may offer a number ofadvantages. For example, the protrusions may enable the seal member tomore easily conform to the irregular shape of the organ, which may aidthe formation of a good seal between the distal edge and the surface ofthe organ. In addition, the protrusions may access sites on the organthat are most conducive to the forming a good seal with the distal edgeand may accommodate patient-to-patient variations in the size and shapeof organs. Further, the protrusions may increase the surface area of theseal between the distal edge and the surface of the organ, which mayincrease the strength of the attachment between the seal member and theorgan and may reduce the likelihood of damage to the surface of theorgan, such as abrasion, laceration, or perforation. The protrusions mayalso expose areas of the organ for surgical procedures that requireaccess to these areas of the organ.

[0018] The details of one or more embodiments of the invention are setforth in the accompanying drawings and the description below. Otherfeatures, objects, and advantages of the invention will be apparent fromthe description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

[0019]FIG. 1 is a profile view of one embodiment of an organmanipulation device.

[0020]FIG. 2 is a bottom view of the seal member of the organmanipulation device shown in FIG. 1.

[0021]FIG. 3 is a cross-sectional view of a protrusion of the organmanipulation device, the cross-section taken at line A indicated inFIGS. 1 and 2.

[0022]FIG. 4 is a cross-sectional view of a protrusion of the organmanipulation device, the cross-section taken at line B indicated inFIGS. 1 and 2.

[0023]FIG. 5 is an enlargement of area D in FIG. 4 showing the distaledge of the seal member.

[0024]FIG. 6 is a cross-sectional view of a nipple of the organmanipulation device, the cross-section taken at line C indicated in FIG.1.

[0025]FIG. 7 is a perspective view of one method of deployment of theorgan manipulation device shown in FIG. 1, with the seal memberincluding three protrusions on the apex of a human heart.

[0026]FIG. 8 is a cross-sectional side view of an alternate embodimentof the organ manipulation device deployed on the apex of a human heart.

[0027]FIG. 9 is a perspective view of another alternate embodiment ofthe organ manipulation device deployed on the apex of a human heart.

DETAILED DESCRIPTION

[0028]FIG. 1 is a profile view of one embodiment of the organmanipulation device 10 of the present invention. In this embodiment,organ manipulation device 10 includes a seal member 12 with a distaledge 14 that extends around the perimeter of seal member 12. Seal member12 includes a central body 16 and three protrusions 18, 20 and 22. Aninner surface 24 and distal edge 14 of seal member 12 cooperate todefine a chamber when seal member 12 is in contact with the surface ofan organ. Seal member 12 may include a vacuum port 28 in fluidcommunication with the chamber.

[0029] Manipulation device 10 may be coupled to a vacuum tube 30. Vacuumtube 30 may facilitate fluid communication between the chamber and avacuum source (not shown). In some embodiments vacuum tube 30 may alsoserve as a support shaft for manipulating device 10. In theseembodiments, vacuum tube must be made of a material of sufficienttensile strength to support the weight of an organ. In otherembodiments, manipulating device 10 may be supported with a dedicatedsupport shaft such as a plastic or metal shaft. In that case, vacuumtube 30 may provide little or no load-bearing capability. Instead,vacuum tube 30 may be disposed proximal to or within such a shaft.Vacuum tube 30 and/or the support shaft may be flexible.

[0030] The proximal portion of seal member 12 may be shaped into ahollow tube or nipple 26. Nipple 26 may define a passage 32, which is influid communication with vacuum port 28. Nipple 26 may be configured toreceive vacuum tube 30 within passage 32. The invention is not limitedto such a coupling, however. Vacuum tube 30 may be coupled to sealmember 12 with any type of connector. The connector may be, for example,a fixed joint, a flexible joint or a swivel connection affixed to theproximal portion of seal member 12 that permits fluid communicationbetween vacuum tube 30 and the chamber via vacuum port 28.

[0031] In addition to receiving vacuum tube 30, nipple 26 may also serveas a connection point between manipulation device 10 and a handle (notshown), which may further facilitate manipulation of the organ, or afixed support (not shown), which may facilitate holding the organ in aposition. Nipple 26 may be connected to a variety of handles or fixedsupports. For example, a collar of rigid material, such as metal orpolymer, can be attached to nipple 26 using adhesive. This rigid collarmay facilitate connection to a handle or fixed support. Alternatively,the external diameter of nipple 26 could be sized and shaped so that itcan be gripped by the clamp of a handle or support. Nipple 26 could alsoitself be used as a handle, allowing a surgeon or assistant tomanipulate or hold the organ. As a further alternative, a handle orsupport could be attached to vacuum tube 30, a dedicated support shaft,or another location on seal member 12 instead of or in addition tonipple 26.

[0032] In embodiments that utilize a vacuum source, the vacuum sourceapplies vacuum pressure to the chamber, which reduces the fluid pressurewithin the chamber and facilitates the adherence of seal member 12 tothe organ. The vacuum source, may, for example, be a simple manualpiston operated vacuum source, such as a syringe with appropriatevalving. In other embodiments, the vacuum source may be a mechanicalvacuum source, such as a rotary pump. The invention is not limited touse with a particular type of vacuum source.

[0033] Vacuum tube 30 may include a valve such as stopcock 34, to allowor prevent air from moving through vacuum tube 30. With stopcock 34open, vacuum pressure may be applied to the chamber using a vacuumsource. Vacuum pressure may be maintained by shutting stopcock 34.Alternatively, the organ may be moved into engagement with seal member12 by the surgeon or assistant, thereby expelling air through openstopcock 34 and through vacuum tube 30. Closing stopcock 34 prevents airfrom entering seal member 12 via vacuum tube 30, and may create apartial vacuum or negative pressure in the chamber without the need foran applied vacuum. Stopcock 34 may also be used to release vacuumpressure, to allow the organ to disengage from seal member 12.Alternatively, a valve may be included in vacuum port 28 or nipple 26.

[0034] The difference between the pressure outside of the seal member 12and inside the chamber forms a substantial seal between edge 14 of sealmember 12 and the surface of the organ. Upon application of vacuumpressure, seal member 12, and particularly protrusions 18, 20 and 22,may deform slightly, conforming to the surface of the tissue and helpingto form the seal. It is preferred that seal member 12 be flexible andcompliant to substantially conform to the irregular surface of the organsuch that the substantial seal may be formed. In embodiments where sealmember 12 is to be adhered to a beating heart, it is further preferredthat seal member 12 be flexible and compliant such that the substantialseal is not affected by the beating of the heart.

[0035] Thus, it is preferred that seal member 12 is made of one or morematerials that exhibit adequate levels of flexibility and compliance.The materials may, for example, include elastomers such as silicone,natural rubber, synthetic rubber, and polyurethane, and more compliantmaterials, such as silicone gel, hydrogel, or closed cell foam. Sealmember 12 in this embodiment includes a one-piece cast of silicone ofsufficiently low durometer to permit deployment and sealing over thecurved surfaces of organs, such as the curved surface of a heart, whilemaintaining sufficient structural integrity under vacuum pressure andthe weight of an organ. The durometer of the silicone may, for example,be within the range from 5 to 50 Shore A.

[0036]FIG. 2 is a bottom view of seal member 12. Edge 14, central body16, protrusions 18, 20 and 22, inner surface 24, and vacuum port 28 arevisible. While seal member 12 of FIGS. 1 and 2 includes threeprotrusions 18, 20 and 22, in other embodiments of device 10 there maybe configurations of seal member 12 with two protrusions or more thanthree protrusions. As shown in FIG. 2, protrusions 18, 20 and 22 aresubstantially equidistant from each other, and of equal length andwidth. Further, in this embodiment, each of protrusions 18, 20, and 22exhibits a long and narrow geometry, with its length two to six timesits width, and tapers slightly toward its tip.

[0037] The configuration of protrusions 18, 20 and 22 depicted in FIGS.1 and 2 has been demonstrated to provide advantages with respect to theattachment of seal member 12 to the irregular and asymmetric shape of aperi-apical site of a heart. This configuration could, however, alsoaccommodate irregular shapes of other organs, such as the kidneys or thestomach. Moreover, the number or protrusions, the angle or distancebetween protrusions, and the length, width and shape of each individualprotrusion may be varied to accommodate a variety of organs andattachments sites thereon. Such alternative configurations are withinthe scope of the present invention.

[0038] Protrusions 18, 20 and 22 may be configured to provide advantageswith respect to attachment of seal member 12 to the organ. Protrusions18, 20 and 22 may enable seal member 12 to more easily conform to theirregular shape of the organ, which may aid the formation of a goodseal. Protrusions 18, 20 and 22 may access sites on the organ that aremost conducive to the forming a good seal with distal edge 14.Protrusions 18, 20 and 22 may accommodate patient-to-patient variationsin the size and shape of organs.

[0039] Edge 14 provides the primary surface area of contact with theorgan and is the surface upon which the force created by the action ofthe vacuum source acts. By increasing the length of edge 14, protrusions18, 20 and 22 may increase the surface area of the seal, increasing thesurface area upon which the force acts. Increasing the surface area ofthe seal increases the force applied to the organ for a fixed level ofpower of the vacuum device, increasing the strength of the attachmentbetween seal member 12 and the organ.

[0040] Increased strength of attachment is advantageous. When graspingor lifting an organ, it is important to provide a robust and stable gripfor the duration of a particular surgical procedure. The duration ofprocedures could range, for example, from 10 to 30 minutes. In the caseof a beating human heart, the weight to be held could typically rangefrom 1.5 to 3.5 pounds. Because dropping the heart during an anastomoticprocedure could cause severe damage to the artery being repaired, it isimportant to hold such weight with a reasonable margin for safety.

[0041] Increasing the area upon which the vacuum force acts may alsoreduce the likelihood of damage to the surface of the organ, such asabrasion, laceration, or perforation. Further, protrusions 18, 20 and 22may expose areas of the organ for surgical procedures that requireaccess to these areas of the organ.

[0042]FIG. 3 is a cross-sectional view of one protrusion, thecross-section taken at line A indicated in FIGS. 1 and 2. FIG. 4 is across-sectional view of one protrusion, the cross-section taken at lineB indicated in FIGS. 1 and 2. In both of FIGS. 3 and 4, edge 14 andinner surface 24 are visible. The relatively flat surface of edge 14facilitates contact between edge 14 and the organ over the substantiallyall of the surface area of edge 14. This in turn facilitates theformation of the seal between edge 14 and the organ. The concavity orcurvature of protrusion 20, and of seal member 12 in general, furtherfacilitates contact between edge 14 and the organ over the substantiallyall of the surface area of edge 14, and facilitates the definition ofthe chamber when seal member 12 is engaged with the surface of theorgan.

[0043] The wall thickness of seal member 12 near its center is generallygreater than the wall thickness at the distal ends of protrusions 18, 20and 22. This distribution of the mass of seal member 12 may beadvantageous. A greater percentage of the weight of the organ issupported near the center of seal member 12, thus a comparatively thickwall in that area may be desired. Near the distal ends of protrusions18, 20 and 22, less weight is supported, and more flexibility may bedesired. Thus, a comparatively thin wall in that area may be desired.

[0044] Thickness 40, as shown in FIG. 3, is a thickness of protrusion 20at point A indicated in FIGS. 1 and 2. Thickness 42, as shown in FIG. 4,is a thickness of protrusion 20 at point B indicated in FIGS. 1 and 2.The difference between thickness 40 and thickness 42 illustrates thisadvantageous distribution. The present invention, however, is notlimited to such a distribution, but instead covers any distribution ofthe mass of seal member 12. For example, a seal member 12 ofsubstantially constant thickness could be employed.

[0045]FIG. 5 is an enlargement of area D in FIG. 4 showing distal edge14 of seal member 12. As shown in FIG. 5, edge 14 can be optionallycoated with a coating 50 that is substantially more compliant andcompressible than edge 14 and seal member 12. Coating 50 may be tacky,which may assist in the adhesion of seal member 12 to the slipperysurface of an organ. Coating 50 may aid in the formation of the sealbetween edge 14 and the organ. Coating 50 may also reduce the likelihoodof damage to the surface of the organ, such as abrasion, laceration, orperforation. Coating 50 may be included at every point on distal edge14, or at selected points.

[0046] Coating 50 could, for example, include a silicone or otherpolymer of a lower durometer than edge 14 and seal member 12. Coating 50could, for example, consist of a silicone gel, hydrogel or closed cellfoam. Use of Shore A 5-10 durometer silicone elastomer for the coating50 may be appropriate for some applications. Silicone gels may bepreferred, however, due to the intrinsic compliance and tackinessprovided by such materials.

[0047] Like silicone elastomers, silicone gels can be manufactured witha range of crosslink densities. Silicone gels, however, do not containreinforcing filler and therefore have a much higher degree ofmalleability and conformability to desired surfaces. As a result, thecompliance and tackiness of silicone gel materials can be exploited incoating 50 to provide a more effective seal.

[0048] Examples of suitable silicone gel materials are MED-6340 andGEL-8150, both commercially available from NUSIL Silicone Technologies,of Carpinteria, Calif. The MED-6340 silicone gel is tacky and exhibits apenetration characteristic such that a 19.5 gram shaft with a 6.35 mmdiameter has been observed to penetrate the gel approximately 5 mm inapproximately 5 seconds. This penetration characteristic is not arequirement, but merely representative of that exhibited by thecommercially available MED-6340 material.

[0049] Each gel is provided as a two-part component liquid, thecomponents designated Part A and Part B, which may be blended together.In general, increasing the ratio of Part A to Part B produces a softerand tackier gel, while increasing the ratio of Part B to Part A producesa firmer less tacky gel. When MED-6340 is mixed in a A:B ratio ofapproximately 1:1, the resulting silicone gel is suitable for use ascoating 50. The material adheres well to slippery organs, such as theheart, and is also easily moldable. In addition, the material minimizestissue abrasion and poses virtually no risk of trauma to the heart.

[0050]FIG. 6 is a cross-sectional view of nipple 26 of manipulationdevice 10, the cross-section taken at line C indicated in FIG. 1.Passage 32 is visible. Nipple 26 is robust enough to support the weightof the organ and distribute lifting or pulling forces to seal member 12and protrusions 18, 20 and 22. In order to provide this robustness,nipple 26 may be relatively thick-walled. The thick walls of nipple 26may also provide structural support for a handle or other fixed support.

[0051] Nipple 26 may also be constructed to be flexible, permittingside-to-side motion, oscillatory motion around the long axis of nipple26, and up and down motion along the long axis of nipple 26. Nipple 26may be made long and flexible to bend without kinking and closingpassage 32. Thus, nipple 26 may be manipulated, or a handle or supportmay be attached thereto, without adversely affecting passage 32. Inembodiments where seal member 12 is to be adhered to a beating heart,the flexibility of nipple 26 may permit the beating motion of the heartto occur without loss of seal and adhesion. The flexibility of nipple 26is particularly advantageous in these situations, because loss of sealand adhesion may, in some circumstances, allow the heart to drop backinto the chest, which may cause trauma to the heart, and may interferewith the progress of the operation.

[0052] In some embodiments of the present invention nipple 26 may belocated in the center of seal member 12. Because of the central locationof nipple 26 in such embodiments, upward force applied to nipple 26 isfairly uniformly distributed to seal member 12 and protrusions 18, 20and 22. In embodiments where seal member 12 is to be adhered to aperi-apical site of a beating heart, the central location of nipple 26provides a further advantage by permitting a surgeon or assistant tolift the heart from the apical region while keeping tension on the longaxis of the heart. The tension prevents bending of the long axis, whichprevents distortion of valves and the decline in cardiac output thatoccurs when the heart is lifted by the surgeon's hand alone.

[0053]FIG. 7 is a perspective view of one method of deployment of theorgan manipulation device 10 shown in FIG. 1, with the seal member 12and protrusions 18, 20 and 22 on the apex of a human heart 60.Protrusions 18 and 20 are visible, while protrusion 22 is obscured byheart 60. Seal member 12 is connected by nipple 26 to vacuum tube 30,which provides suction from the vacuum source to adhere seal member 12to heart 60 as described above.

[0054] A person, such as a surgeon or assistant, may position sealmember 12 on the heart before applying suction from the vacuum source toadhere seal member 12 to heart 60. Using a device with a seal memberwith two or more protrusions permits positioning the device on heart 60in a position such that it conforms to asymmetric and irregularsurfaces, including such features as fat deposits. The person canmanually position seal member 12 to achieve optimal sealing under vacuumprior to lifting or manipulating device 10 and heart 60. The person canfurther position seal member 12 so as not to obscure importantstructures on heart 60, such as the coronary arteries. The person canfurther position seal member 12 so as not to interfere with thehemodynamics of heart 60 when manipulating heart 60, if heart 60 isbeating.

[0055] The person may apply vacuum pressure to adhere seal member 12 toheart 60 by any of the means described above. When seal member 12 isadhered to heart 60, nipple 26, or a handle or fixed support affixedthereto, may be used to lift or support heart 60.

[0056] In some alternative embodiments of the present invention, organmanipulation device 10 may also be used to pace heart 60. FIG. 8 is across-sectional side view of such an embodiment of device 10, includingseal member 12 and electrodes 70 and 72 incorporated within seal member12 that deliver pacing pulses to heart 60. Seal member 12 is showndeployed on the apex 74 of the heart 60. In the embodiment depicted inFIG. 8, electrodes 70 and 72 are located within distal edge 14 of sealmember 12.

[0057] Electrodes 70 and 72 may be located anywhere within or proximateto distal edge 14, central body 16 or protrusions 18, 20 and 22 (notvisible in FIG. 8), as long as contact between electrodes 70 and 72 andthe surface 76 of heart 60 is possible. There may be little contact, forexample, where chamber 29 is defined by seal member 12 and heart 60.Contact between electrodes 70 and 72 and surface 76 may be most likelyto occur when electrodes 70 and 72 are located within or proximate todistal edge 14. Surface 76 may be the pericardial sac of heart 60, orthe epicardium of heart 60 if the pericardial sac is opened.

[0058] Electrodes 70 and 72 may be used to pace heart 60 by stimulationof the bundles of His 78 and 80, and Purkinje fibers 82. The normalpacemaker of heart 60 is the sinoatrial (SA) node (not shown in FIG. 8).The SA node is a small specialized region in the right atrial wall nearthe opening of the superior vena cava. An action potential initiatedwithin the SA node ordinarily spreads to both atria of heart 60. Aninternodal pathway extends from the SA node to the atrioventricular (AV)node (not shown in FIG. 8), which is a small bundle of specializedcardiac muscle cells near the junction of the atria and the ventricles84 and 86. Specialized cells known as the bundle of His extend from theAV node, through the ventricular septum 88, where they divide into theleft branch bundle of His 78 and the right branch bundle of His 80. Thebranch bundles of His 78 and 80 curve around the tips of ventricularchambers 84 and 86, and travel back toward the atria along the outerwalls of heart 60.

[0059] Following receipt of an impulse by the AV node from the SA node,and after a brief AV nodal delay, the impulse travels rapidly down thebundles of His 78 and 80. Purkinje Fibers 82 extend from bundles of His78 and 80 and spread throughout the ventricular myocardium 90. Theimpulse transmitted by the bundles of His 78 and 80 is carriedthroughout the ventricular myocardium 90 by Purkinje fibers 82. Thebundles of His 78 and 80 and Purkinje fibers 82 have a normal rate ofaction potential discharge of 20 to 40 action potentials per minute.

[0060] Stimulation of bundles of His 78 and 80 and Purkinje fibers 82may cause the ventricular myocardium to beat at a faster rate and thehelp pace heart 60. Electrodes 70 and 72, which may be coupled to avoltage or current source (not shown in FIG. 8) via conductors, may inthis way be used to stimulate the bundles of His 78 and 80 and Purkinjefibers 82 and help pace heart 60.

[0061] Any number of electrodes may be included within seal member 12,and used to pace heart 60. Because seal member 12 adheres atraumaticallyto apex 74, device 10 can remain on apex 74 for long periods of timewithout causing hematoma or other trauma. In addition, the placement ofseal member 12 on apex 74 allows for minimal interference with thesurgical field. Consequently, device 10 can pace heart 60 when needed,and can remain in place when pacing is not required.

[0062]FIG. 9 is a perspective view of another alternate embodiment ofthe organ manipulation device 10 deployed on the apex of heart 60. Inthis embodiment, seal member 12 comprises a central member 100 and adistal skirt-like member 102.

[0063] Central member 100 is connected to vacuum tube 30. In thisembodiment, central member 100 is also connected to a dedicated supportshaft 106, which may support most or all of the weight of the organ.Vacuum tube 30 may provide little or no load-bearing capability. Supportshaft 106 may provide no vacuum pressure to manipulation device 10.

[0064] Support shaft 106 and vacuum tube 30 need not be coupled tocentral member 100 in the same way. In FIG. 9, support shaft 106 iscoupled to central member 100 with a swivel connection 110. Vacuum tube30 is flexible and is coupled to central member 100 with a fixedconnection 112. Swivel connection 110 and the flexibility of vacuum tube30 cooperate to accommodate the beating motion of heart 60 whilemaintaining a good seal and good adhesion.

[0065] In the embodiment shown in FIG. 9, both central member 100 andskirt-like member 102 cooperate to define a plurality of protrusions 104a, 104 b (hereinafter collectively 104) that extend radially outwardfrom the center of seal member 12. Protruding structures 108 a, 108 b(hereinafter collectively 108) extend outward from the center of centralmember 100, and protrusions 104 extend from the protruding structures108. Protruding structures 108 may enhance the structural integrity ofprotrusions 104 by, for example, causing protrusions 104 to be orientedin a particular direction.

[0066] As shown in FIG. 9, protrusions 104 need not be of uniform sizeor shape. Protrusion 104 a, for example, may extend further outward fromthe center of seal member 12 than protrusion 104 b. Similarly protrudingstructures 108 need not be of uniform size or shape. Protrudingstructure 108 a may extend further outward from the center of centralmember 100 than protruding structure 108 b. Manipulation device 10 mayinclude additional protrusions and protruding structures that are notshown in FIG. 9. Manipulation device 10 may include, for example, twoother protrusions and protruding structures that are not visible in FIG.9. The protrusions and protruding structures may be, but need not be,sized or shaped similarly to protrusions 104 and protruding structure108 that are depicted in FIG. 9.

[0067] The invention is not limited to any particular shape of centralmember 100, however. In some embodiments, skirt-like member 102 mayalone define protrusions 104, while central member 100 includes noprotruding structures. Central member 100 may have, for example, acup-like shape.

[0068] Central member 100 may be formed from many materials, includingthermoplastic such as polycarbonate, ABS, polysulfone, polyester andpolyurethane, and including corrosion-resistant metals such as titanium,and including rigid and semi-rigid elestomers such as a silicone rubber,natural rubber, synthetic rubber, and polyurethane. Central member 100may have a semi-rigid structure that may be somewhat compliant, butgenerally resistant to deformation. As an example, central member 100may be formed from silicone elastomers in the range of Shore A 30 to 75durometer.

[0069] Skirt-like member 102, in contrast, may be formed from asubstantially compliant material, such as a silicone elastomer, siliconegel, hydrogel, closed cell foam or combinations thereof. Skirt-likemember 102 generally permits deformation upon contact with tissue. Inthis manner, central member 100 imparts structural integrity tomanipulation device 10, while skirt-like member 102 provides a sealinterface with the tissue of an organ, such as heart 60. Also, thematerial forming skirt-like member 102 may be tacky, and thereby promoteadhesion to the surface of the organ. Use of Shore A 5-10 durometersilicone elastomer for the skirt-like member 102 may be appropriate forsome applications. Silicone gels may be preferred, however, due to theintrinsic compliance and tackiness provided by such materials. MED-6340and GEL-8150 are examples of suitable silicone gels that may be employedto form skirt-like member 102.

[0070] The invention can provide one or more advantages. For example,protrusions may enable a seal member to more easily conform to theirregular shape of the organ, which may aid the formation of a good sealbetween the seal member and the surface of the organ. In addition, theprotrusions may help the manipulation device adhere to sites on theorgan that are most conducive to the forming a good seal with the distaledge and may accommodate patient-to-patient variations in the size andshape of organs. Protrusions may also accommodate motion of the organwithout a loss of the seal or adhesion.

[0071] Further, the protrusions may increase the surface area of theseal between the distal edge and the surface of the organ. An increasedsurface area may increase the strength and robustness of the adherencebetween the seal member and the organ. An increased surface area mayalso reduce the likelihood of damage to the surface of the organ, suchas injury due to abrasion, laceration, or perforation.

[0072] Protrusions may also expose areas of the organ for surgicalprocedures that require access to these areas of the organ. When placedproximate to the apex of the heart, for example, the manipulation devicemay be oriented to expose a desired region near the apex. Furthermore,the protrusions may be configured with a variety of shapes to allowattachment of a manipulation device to a variety of sites on a varietyof organs for a variety of surgical procedures.

[0073] The seal member may be made materials that are substantiallycompliant such that the seal member substantially conforms to thesurface of an organ, which in turn promotes formation of a substantialseal between the seal member and the surface of the organ. The sealmember and protrusions may exhibit a concave shape, which may alsopromote the formation of the substantial seal. The distal edge of theseal member may be coated with a coating, such as silicone gel, whichmay be tacky. The coating may further promote formation of a substantialseal, and may reduce the likelihood of damage to the surface of theorgan.

[0074] Where a vacuum tube or a dedicated support member is attached tothe manipulation device by a nipple that is flexible, the flexibility ofthe nipple may accommodate the beating motion of a heart without loss ofseal and adhesion. The nipple may provide a convenient attachment for ahandle, which allows a surgeon or assistant to manipulate an organ, or afixed support, which may be used to hold an organ in place. Inembodiments where the nipple is located near the center of the sealmember, the central location permits a surgeon or assistant to lift aheart from the apical region while keeping tension on the long axis ofthe heart. The tension prevents bending of the long axis, which preventsdistortion of valves and the decline in cardiac output that occurs whenthe heart is lifted by the surgeon's hand alone.

[0075] Various embodiments of the invention have been described. Theseembodiments are illustrative of the practice of the invention. Variousmodifications may be made without departing from the scope of theclaims. For example, the invention encompasses manipulation deviceshaving protrusions of a variety of shapes, sizes and positions. AlthoughFIGS. 1 and 2, for example, depict a seal member including threeprotrusions, the number or protrusions may be varied. Moreover, theangle or distance between protrusions, and the length, width and shapeof each protrusion may also be varied. These variations may allowattachment of the manipulation device to a variety of sites on a varietyof organs for a variety of surgical procedures.

[0076] One example of an alternative configuration may include twoprotrusions extending in opposite directions from the central body, withthe protrusions increasing in width towards their distal ends. In thisconfiguration, the device may resemble a bowtie or a propeller. Anotherexample of an alternative configuration may include two protrusions ofapproximately equal length separated by an angle of 180 degrees, and twosubstantially shorter protrusions, each equidistant from the two longerones. The invention encompasses all of these variations.

[0077] The seal member need not be made of silicone, and need not beflexible. Nor is the seal member limited to a generally concave shape.As illustrated by FIG. 9, the seal member is not limited to single-piececonstruction, but may instead comprise two or more components.

[0078] The distal edge shown in the figures is exemplary. The distaledge need not be substantially flat, but may be shaped with a topographythat enhances attachment to a particular organ or site. The distal edgeor the coating on the device need not be smooth, but may be textured toenhance attachment to an organ.

[0079] The vacuum tube may be load-bearing or non-load-bearing. Thevacuum tube need not be flexible. For example, the vacuum tube maycomprise a segmented hollow articulable arm that allows manipulation andpositioning of an organ and may be locked to provide support for theorgan in a position. Coupling of a manipulation device to any type ofvacuum tube is within the scope of the present invention.

[0080] In some embodiments of the invention, Moreover, the manipulationdevice need not be coupled to a vacuum tube at all. A surgeon may movethe organ and/or the seal member to displace air from the chamberdefined when the seal member is in contact with the surface of theorgan. In some circumstances, displacement of air may be sufficient tocreate a seal between the device and the organ.

[0081] The nipple as depicted in FIGS. 1, 7 and 8 is merely exemplary,as are the flexible and fixed connections shown in FIG. 9. The inventionis not limited to the particular connections shown. In addition, theinvention encompasses embodiments in which a flexible joint or swivelconnection is a part of a vacuum tube or a support shaft, or both. Theinvention also encompasses embodiments in which a flexible connector isan integral part of the central body.

[0082] Moreover, features from some embodiments described herein may beincorporated into other embodiments. For example, the manipulationdevice depicted in FIG. 1 may be adapted to include the multi-piececonstruction shown in FIG. 9.

[0083] Furthermore, the manipulation device is not limited to attachmentto a peri-apical site of a heart, nor is the manipulation device limitedto use during CABG. Rather, the various embodiments of the manipulationdevice may be used in any surgical procedure that may involvemanipulation of an internal organ.

[0084] These and other embodiments are within the scope of the scope ofthe following claims.

1. A device comprising: a seal member to contact a surface of an organ,the seal member including an inner surface, a central body, and at leasttwo protrusions that extend outward from the central body. wherein theinner surface defines a chamber when the seal member is in contact withthe surface of the organ.
 2. The device of claim 1, wherein the sealmember includes at least three protrusions.
 3. The device of claim 1,wherein the protrusions are located equidistant from each other.
 4. Thedevice of claim 1, wherein the protrusions are of equal size and shape.5. The device of claim 1, wherein the protrusions exhibit a long andnarrow geometry.
 6. The device of claim 1, wherein each protrusionincludes a proximal end and a distal end, and wherein the width of aprotrusion tapers from the proximal end to the distal end.
 7. The deviceof claim 1, wherein each protrusion includes a proximal end and a distalend, and wherein the thickness of a protrusion tapers from the proximalend to the distal end.
 8. The device of claim 1, wherein the protrusionsare substantially flexible and compliant.
 9. The device of claim 1,wherein the seal member is formed from silicone.
 10. The device of claim1, wherein the seal member includes a distal edge that extends aroundthe perimeter of the seal member and contacts a surface of the organ.11. The device of claim 10, further comprising a coating located on thedistal edge.
 12. The device of claim 11, wherein the coating is tacky.13. The device of claim 11, wherein the coating comprises silicone gel.14. The device of claim 1, wherein the seal member further includes avacuum port in fluid communication with the chamber.
 15. The device ofclaim 14, further comprising a valve to regulate fluid flow through thevacuum port.
 16. The device of claim 1, further comprising: at least oneof a vacuum tube and a support shaft; and a connector connected to atleast one of the vacuum tube and support.
 17. The device of claim 16,wherein the connector is located on a proximal end of the seal member.18. The device of claim 16, wherein the connector is formed integrallywith the seal member.
 19. The device of claim 16, wherein the connectoris flexible.
 20. The device of claim 16, wherein the seal member furtherincludes a vacuum port in fluid communication with the chamber, andwherein the connector is in fluid communication with the vacuum tube andthe vacuum port.
 21. The device of claim 16, further comprising ahandle, the handle attached to at least one of the seal member, theconnector, the tube and the support shaft.
 22. The device of claim 16,further comprising a fixed support that holds the organ in a position,the fixed support attached to at least one of the seal member, theconnector, the tube and the support shaft.
 23. The device of claim 1,further comprising an electrode affixed to the seal member.
 24. Thedevice of claim 23, wherein the electrode is located on the distal edge.25. The device of claim 1, wherein the seal member comprises a centralmember and a skirt-like member.
 26. The device of claim 25, wherein theskirt-like member is substantially compliant and tacky, and whereincentral member is less deformable than the skirt-like member, therebyimparting structural integrity to the seal member.
 27. A devicecomprising: a seal member to contact a surface of an organ, the sealmember including a central member and skirt-like member, wherein theskirt-like member includes at least two protrusions that extend outwardfrom the central member.
 28. The device of claim 27, wherein theskirt-like member is substantially compliant and tacky.
 29. The deviceof claim 27, wherein central member is less deformable than theskirt-like member, thereby imparting structural integrity to the sealmember.
 30. The device of claim 27, wherein the seal member includes aninner surface that defines a chamber when the seal member is in contactwith the surface of the organ.
 31. The device of claim 30, wherein theseal member further includes a vacuum port in fluid communication withthe chamber.
 32. The device of claim 27, wherein the skirt-like memberfurther includes a distal edge extending around the perimeter of theskirt-like member.
 33. The device of claim 32, further comprising acoating located on the distal edge that is more compliant and tacky thanthe skirt-like member.
 34. The device of claim 27, further comprising atleast one of a handle and a support affixed to the device configured topermit the device to be manipulated and to be immobilized relative to abody of a patient.
 35. The device of claim 27, wherein the centralmember includes a protruding structure that extends outward from thecenter of the central member, wherein at least one protrusion extendsfrom the protruding structure.
 36. The device of claim 27, wherein thecentral member has a cup-like shape.
 37. A method comprising: bringing aseal member into contact with a surface of an organ to define a chamber,the seal member having at least two protrusions; bringing theprotrusions into contact with the surface of the organ; and applyingvacuum pressure to the chamber to adhere the seal member and theprotrusions to the surface.
 38. The method of claim 37, wherein applyingvacuum pressure comprises causing at least one of the protrusions todeform slightly.
 39. The method of claim 37, wherein applying vacuumpressure comprises forming a seal between the seal member and thesurface of the organ.
 40. The method of claim 37, wherein applyingvacuum pressure comprises closing a valve to maintain a first fluidpressure within the chamber at a lower value than a second fluidpressure outside of the seal member.
 41. The method of claim 37, furthercomprising manipulating the organ by manipulating the seal member. 42.The method of claim 41, wherein manipulating the organ comprisesmanipulating the organ by manipulating a handle attached to the sealmember.
 43. The method of claim 42, further comprising: moving the organfrom a first position to a second position; and maintaining the organ inthe second position by attaching the seal member to a support.
 44. Themethod of claim 37, wherein the organ is a heart, further comprisingdelivering pacing pulses to the heart.